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为了解临床试验知情同意主要对象即患儿法定监护人对药物临床试验的认识、态度及关注点,以探讨儿童受试者保护方案和临床试验教育策略,提高儿童临床试验的参与度和依从性。通过分层随机抽样在某三甲儿童综合医院随机调查300位监护人,以住院病房为单位,每个病房随机抽取12张病床作为抽样床位,该床位住院患儿法定监护人即为调查对象,发现有较高受教育程度、较高家庭月收入以及听说过临床试验的监护人对临床试验的认识更好;受试者直接获益、受试者风险、受试者保护、经济利益是监护人的主要关注点,建议通过提高监护人认识、加强医患沟通和加强有效的伦理审查等保护受试者权益,促进儿童药物临床试验的合理开展。
To understand the main target of informed consent in clinical trials, that is, the legal guardian of children cognition, attitude and focus on drug clinical trials to explore child protection programs and clinical trial education strategies to improve children’s clinical trial participation and compliance. A total of 300 randomly assigned guardians were investigated by stratified random sampling in a third-grade children’s general hospital. In-patient wards, 12 beds were randomly selected in each ward as sampling beds. The legal guardian of children with in-bed was found to be more Higher education, higher monthly household income, and guardians who have heard of clinical trials are better informed of clinical trials; direct benefit to the subject, subject risk, subject protection, economic benefits are major concerns of guardians It is suggested that the protection of the rights and interests of the subjects should be protected by raising the awareness of guardians, strengthening the communication between doctors and patients and strengthening the effective ethics review so as to promote the rational development of clinical trials of children’s medicines.